To market a dietary supplement with a “New Dietary Ingredient (NDI)” in the United States (US), manufacturers are required to submit a notification to the Food and Drug Administration (FDA). This requirement falls under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and it is aimed at ensuring the safety of ingredients used in dietary supplements under the specified and recommended conditions.
If a manufacturer is planning to launch their product (containing an NDI) in the US, they are required to submit the NDIN application to the FDA at least 75 days prior to the proposed date of introduction of the product in the market. An NDIN application must contain the information required to prove the safety of an NDI. However, as per the Act, if the ingredient has been marketed as a dietary supplement in the US, prior to October 15, 1994, it is not subjected to the NDIN requirement.
Although the notification process is quite hassle-free, the condition of misinterpreting the Regulatory requirements can result in product recall. Therefore, along with the basic knowledge of NDIN, manufacturers must also be aware of the following:
- FDA’s perspective on NDIN over the time
- Criteria for choosing NDIN over GRAS
- Regulatory analysis of the Food Ingredient/s under the DSHEA 1994
- NDIN: Process, Approval and Timeline
- Notification to the FDA and submission requirements
- Timeline and documents to be submitted
- Submission modes and Post-submission NDIN process
- Potential advantages and risks of NDIN
Given the key aspects to be decoded for successful NDI notification, it is always good to approach the best source of information to fool proof your compliance strategies. Here is one such informative source you can bank on – Freyr’s informative webinar on “New Dietary Ingredient Notification (NDIN) Application – Food and Dietary Supplements in the USA.” Decode the best possible insights about the US FDA NDIN.